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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, acupressure
510(k) Number K142471
Device Name Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip
Pressure Point Inc.
936 Green Meadow Drive
tinton falls,  NJ  07724
Applicant Contact joseph dilustro
Emergo Group
816 Congress Avenue, Suite 1400
austin,  TX  78701
Correspondent Contact julie powell
Classification Product Code
Date Received09/03/2014
Decision Date 12/01/2014
Decision substantially equivalent (SESE)
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No